RecruitingNot ApplicableNCT06322888

Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)


Sponsor

Dana-Farber Cancer Institute

Enrollment

46 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. The names of the study groups in this study are: * Exercise Training Group * Waitlist Control Group


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 59 Years

Inclusion Criteria6

  • Women aged 18-59
  • Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months
  • Physically inactive; engaging in \<60 minutes of moderate or vigorous intensity exercise per week, as assessed by Godin Leisure Time screener
  • Not pregnant or breastfeeding
  • English speaking and able to read English. Investigators are only enrolling English-speaking participants to this study at this time due to the fact that investigators currently only have English-speaking exercise trainers with the proper qualifications to conduct the exercise training
  • Written informed consent prior to any study-related procedures

Exclusion Criteria7

  • Self-reported inability to walk 2 blocks (at any pace)
  • Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated
  • On oral or implantable hormonal contraceptives, postmenopausal hormone replacement therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena or other IUD is acceptable
  • Consistent strength training in the past 3 months
  • Use of weightloss drugs
  • Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate exercise. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility
  • Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)

Interventions

BEHAVIORALExercise Training Program

A 12-week aerobic and resistance-training exercise intervention with a certified exercise trainer in person or virtually. FitBit activity tracker, resistance bands, hand weights, and stationary bike will be provided to participants. Hand weights will be returned at end of study.


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06322888


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